Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicant’s claim amendments and arguments filed in the response filed on 15 January 2026 are acknowledged.
Claims 1-11, 20, 21, 23-34 & 36-47 are pending.
Claims 12-19, 22 & 35 are cancelled.
Claims 1-3, 5, 7, 23, 24, 26, 27, 28, 33, 34, 36 & 39-47 are amended.
Claims 5, 6 & 23-25 are withdrawn for being drawn due to the claims being drawn to an unelected species of at least one additional chlorin compound.
Claims 1-4, 7-11, 20, 21, 26-34, & 36-47 are under consideration.
Examination on the merits is to the extent of the following species:
Further step in claim 9- subgroup (a) in which a combination of one or a combination of (i) 6-piperidin-1-ylpyrimidine- 2,4-diamine 3-oxide, (ii) a 5-a reductase inhibitor selected from the group of 4-azasteroid compounds, aldosterone receptor antagonists, or (iii) a retinoid is administered -and-
At Least One Additional chlorin- copper chlorin p6.
Withdrawn Objections/Rejections
The objection to claim 47 is withdrawn due to deletion of the second period.
Claims 1-4, 7-11, 20-25, 32-39 & 42 under 35 USC 112(a)-New Matter is withdrawn due to removal of the lower limit of 0.001% for the active ingredient from claims 1, 26 & 44.
The rejection of claim 7 under 35 USC 112(a)-New matter is withdrawn due to claim amendments which delete limitations pertaining to the carrier.
The rejection of claims 33 & 34 under 35 USC 112(a)-New matter is withdrawn due to amendments which delete water from the constituents of the carrier.
The rejection of claim 35 under 35 USC 112(a)-New matter is withdrawn due to cancellation of the claim.
The rejection of claims 37 & 40-42 under 35 USC 112(a)-New matter is withdrawn due to amendments which recite the structure the percentages are based from are the composition, not the carrier.
The rejection of claim 43 under 35 USC 112(a)-New matter is withdrawn due is withdrawn due to amendment which recite the species of active ingredient from original claims 1 and 2.
The rejection of claim 40 under 35 USC 112(a) is withdrawn due to amendments which clarify the ingredients for the composition.
The rejection of claim 42 under 35 USC 112(a) is withdrawn due to amendments which stipulate carrier reagents and amounts which have support in the specification and example.
The rejection of claim 43 under 35 USC 112(a)-New Matter is withdrawn due to recitation of trisodium copper (II) chlorin e6 and disodium copper (II) isochlorin e4 as the “one or more chelated copper compounds”. The claim changes the scope of the disclosure, thereby introducing NEW MATTER
The rejection of claims 44-47 under 35 USC 112(a)-New Matter is withdrawn due to removal of the lower limit of 0.001% for the active ingredient from claim 44.
The rejection of claim 46 under 35 USC 112(a)-New Matter is withdrawn due claim amendments to recite specific percentages and species of copper chlorins and the recitation of “the one or more chelated copper chlorin compounds are the only active ingredients in the topical hair volumizing composition useful in increasing the density or the diameter of terminal hairs”.
The rejection of claim 43 under 35 USC 112(b) is withdrawn due to Applicant’s persuasive argument that the claim is independent.
The rejection of claim 1, 9, 10, 11, 32, 44 & 45 under 35 U.S.C. 103 over McDaniel (US 2009/0197954; 08/06/2009) and McCook [WO 2011/050102]; claims 3, 4, 20, & 43 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel and McCook 2011 and further in view Woodward; claim 8 over McDaniel and McCook 2011 and further in view of Cleveland Clinic; claims 7, 33, 35 & 39 over McDaniel [as evidenced by Qin], McCook 2011,and further in view of McCook 2015(b) and Kunin; claims 36-38 over McDaniel [as evidenced by Qin], McCook 2011, McCook 2015(b) Kunin and further in view of Kamis; claim 21 is over McDaniel and McCook 2011 and further in view of Gaunitz; and claim 34 is over McDaniel, McCook 2011, and Gaunitz, and further in view of McCook 2015(b) and Kunin is withdrawn due to claim 1 & 44 amendments which recite the amounts of reagents and inclusion of a phospholipid.
The rejection of claim 26 under 35 U.S.C. 103 as being unpatentable over McDaniel (US 2009/0197954; 08/06/2009;), McCook [(Published: 08/12/2015); hereinafter McCook 2015(b); previously cited] and McCook (WO 2017/027177; Published: 02/16/2017; hereinafter McCook 2017]; claim 27 over McDaniel, McCook 2015(b) and McCook 2017, as applied to claim 26 above, and further in view of Klemp (Published: 1989; previously cited) and Liu (CN 110090211; Published: 08/06/2019; previously cited); claims 28-31 over McDaniel, McCook 2015(b) McCook 2017, Klemp and Liu as applied to claims 26 & 27 above, and further in view of Woodward (US 20150320661; previously cited); and claim 41 over McDaniel, McCook 2015(b), and McCook 2017 and further in view of McCook 2015(b) and Kunin is withdrawn due to amendments which recite the amount of carrier and active ingredient.
The provisional rejection of claims 1-4, 20, 26-30,44, 45, & 47 on the ground of nonstatutory double patenting as being unpatentable over claims 9, 10, 12-15 & 18-21 of copending Application No. 19/192,917 is withdrawn due to claim amendments which recite a phospholipid or reagents and their amounts.
Objections/Rejections
Claim Objections
-Claims 3, 7, 12-19, 40 & 43-46 are objected to because of the following informalities:
Claims 3, 7, 40 & 43 & 46 have the informal language “salts of the above listed chlorin compounds”.
Applicant may wish to consider whether amending the claims to formal claim language such as claim 2 would obviate the objection.
Cancelled claims 12-19 are not 37 CFR 1.121 compliant having the informal direction of “Cancel Claims 12-19) rather than the formal claim status identifiers of “Claims 12-19 (Cancelled)”. Failure to comply with 37 CFR 1.121 in the future will result in a Notice of Noncompliant Amendment.
Claim 44 is missing deleted content/strikethroughs. This deleted content/strikethroughs have now become a part of claim 45. The claim is not 37 CFR 1.121 compliant.
The typesetting of claim 45 has deleted content/strikethroughs from claim 44 prior to the claim 45 status identifier (see claims filed 08/19/2025 for comparison). The claim is not 37 CFR 1.121 compliant.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 7-11, 20, 21, 26-34 & 36-47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 recites percentages for the generically recited “carrier”, and “phospholipid”. Applicant states support for the ranges of amounts for these genera is found in Example A (reply, pg. 17). This is not persuasive. Example A is drawn to specific reagents for the carrier (i.e. SD alcohol, butylene glycol and ethoxydiglycol) and lecithin or phosphatidylcholine or lecithin for the phospholipid. Support is not present for the broader recitation of carrier”, and “phospholipid”. Applicant’s amendment change the scope of the disclosure, thereby constituting new matter.
Claims 2-4, 7-11, 20, 21, , 32-34 36-39 & 42 are rejected under 35 USC 112(a) because they ultimately depend from rejected claim 1.
The analysis is the same for claims 26 (as it pertains to an alcohol and a glycol), 40 (as it pertains to the denatured alcohol), 44 & 47 (as it pertains to phospholipid).
Claims 27-31 & 41 are rejected under 35 USC 112(a) because it depends from rejected claim 26.
Claim 45 is rejected under 35 USC 112(a) because it depends from rejected claim 44.
Claim 37 is rejected under 35 USC 112(a)-New matter because page 8 of the specification teaches the composition comprises ethoxydiglycol, not the carrier. Applicant argues ethoxydiglycol is a glycol and one would understand it to be a carrier. Applicant points to paragraph [0031] of copending Serial No. 19/192917 to argue that pharmaceutical vehicles is a term interchangeably used with carrier (reply-pg. 19). This is not persuasive. The instant application does not have priority to Serial No. 19/192917. Serial No. 19/192917 is its own application and will be evaluated on its own merits. It is not germane to the issue at hand. The as filed specification clearly points out that ethoxydiglycol, and the amounts taught for it, are in relation to the composition and not the carrier (see Example A -pg. 8). Applicant’s amendment change the scope of the disclosure; thereby constituting new matter.
Claim 43 recites a method in the active ingredient present in a concentration of 0.001 to 0.1% is applied to the scalp. The claim 43 method recites the active ingredient one or more chelated copper compounds comprising “(a) at least 75% by weight of a chlorin species selected from the group consisting of trisodium copper (II) chlorin e6 and disodium copper (II) isochlorin e4; or (b) (i) at least 30% by weight disodium copper (II) isochlorin e4 and (ii) at least one chlorin compound selected from the group consisting of:…” Applicant argues “these claims have been amended to either (1) recite the narrower range of 0.02-0.1 % for the genera of chelated copper chlorin compounds per Example A or (2) recite one or more of the specific types or combinations of chelated copper chlorins described on pages 3-4 of the Specification”. This is not persuasive because support for these recited species are found in original claims 1 and 2 and the concentration associated with these were 0.02 to 0.1% by weight of the composition. The recited concentration of 0.001 to 0.1% is not supported. Applicant’s amendment change the scope of the disclosure; thereby constituting new matter.
The analysis is the same for claims 40 (as it pertains to the chorins) & 46.
Claim 47 recites a composition comprising a phospholipid and pH adjusting agent in unitless amounts. Applicant states support for the ranges of amounts for these genera is found in Example A (reply, pg. 17). This is not persuasive. Example A is drawn to specific reagents, lecithin or phosphatidylcholine for the phospholipid in a specific range and the pH adjusting agent in a specific range. They are not generically taught. They are also not taught as being present in any undisclosed amount. Support is not present. Applicant’s amendment change the scope of the disclosure, thereby constituting new matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 9-11, 32 & 33 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel (US 2009/0197954; 08/06/2009; previously cited), Montanari (US 2020/0164037; Published: 05/28/2020), McCook [WO 2011/050102; hereinafter McCook 2011, previously cited and referenced as McCook 2011].
McDaniel teaches a composition and a method for treating age-related alopecia (title). With regard to claims 1, 10 & 11, McDaniel teaches application of the topical preparation to the scalp (i.e. an area that is 700 cm2) to slow or stop the microinflammation in scalp follicles that would otherwise lead to fibrosis and miniaturization of the follicle seen clinically as baldness [0018]. With regard to claim 1, McDaniel teaches carriers (McDaniel’s claim 1). With regard to claim 9, McDaniel teaches that it is hypothesized that minoxidil (i.e. 6-piperidin-1-ylpyrimidine-2,4-diamine 3-oxide) grows hair by “blocking intracellular production of enzymes or substrates that cells might produce as a result of being told to stop growing by binding of DHT to their androgen receptors” [0006]. It would have been prima facie obvious to the ordinary skilled artisan, at the time of filing, to have added the step of administering minoxidil to the scalp in conjunction with McDaniels method because McDaniel is directed to the growing hair and administration of minoxidil grows hair. The ordinary skilled artisan, would have been motivated to do so, with an expectation of success, in order to grow hair by treating another mechanism through which hair loss occurs. With regard to claims 10 & 11, the density or diameter of the terminal hairs is necessarily increased as compared to an untreated person because the “miniaturization of the follicle seen clinically as baldness” is decreased [0018]. With regard to claims 10 & 32, McDaniel teaches in Example 1 that “this inventor has observed increased terminal (full sized) hair growth in the balding scalp of a 60 year-old man treated for five months for cystic acne with the medication” which is 13-cis-retinoic acid/a retinoid (i.e. 150 days; “(2) an average diameter of the terminal hairs increases by greater than 5% after the period of time compared to the average diameter prior to the period of time). With regard to claims 10 & 11, McDaniel teaches following a competing product of minoxidil in which it took 6 months to observe hair growth when topically applied [0006]. It would have been prima facie obvious to the ordinary skilled artisan, at the time of filing, to have modified McDaniel’s method by adjusting the period of administration to 180 days (i.e. 6 months) because this is done in the alopecia arts because related topical products such as minoxidil take six months to regrow hair. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to select an administration period art recognized as suitable for observing hair regrowth.
McDaniel does not teach inclusion of “26.7-62.76% water…and 0.02-0.1 of a chelated copper chlorin compound”
In the same field of invention, Montanari teaches a composition to stimulate hair growth (title). With regard to claims 1 & 33, Montanari in Example 1 teaches a lotion to stimulate hair growth comprising glycerin, pentylene glycol, caprylyl glycol and decylene glycol (i.e. carrier) in a combined amount of 0.10003-40%; “alcohol denat.” in an amount from 0.1-99%, phosphatidylcholine (phospholipid) in an amount of 0.0001-10%, disodium EDTA (i.e. antioxidant) in an amount of 0.0001-1%, sodium hydroxide (i.e. pH adjusting agent) in an amount of 0.0001-10%, and “water in q.b (sic) 100” [00097]. Montanari teaches their invention has an effect inflammation with ”platelets promote regeneration and modulate the inflammatory response by releasing growth factors, cytokines and other regulatory molecules” [0011].
In the same field of invention of hair thinning, McCook 2011 teaches “A fifth aspect of the present invention is directed to methods and formulations for the topical treatment of thinning hair or alopecia comprising topical administration of (i) chlorophyllin, chlorin e4, chlorin e6, or ethyl esters of chlorin e4 or e6, the chlorins or chlorin ethyl esters preferably in the form of the sodium or potassium salts of their copper and zinc complexes” (i.e. sodium copper chlorin e6; [0014]). McCook 2011 also teaches a “further embodiment… directed to method of treatment of inflammatory dermatoses selected from the group consisting of… alopecia areata… The method includes the step of topically administering to an area of skin affected by the inflammatory dermatosis a composition comprising (i) chlorophyllin, chlorin e4, chlorin e6, or ethyl esters of chlorin e4 or e6, the chlorins or chlorin ethyl esters preferably in the form of the sodium or potassium salts of their copper and zinc complexes” (emphasis added; [0068]). McCook teaches the suitability of the ethylhexyl stearate which is an art recognized fatty compound and emollient (Example 1 –[0037]; Example 45-[0164]). With regard to claim 1, In Example 15, McCook 2011 teaches a gel comprising water, butylene glycol and simethicone emulsion (i.e. carrier), lecithin (i.e. phospholipid), vitamin E acetate (i.e. antioxidant), sodium hydroxide (pH adjusting agent) and sodium copper chlorin e6 containing gel in an amount of 0.1% [0101]. With regard to claims 1, in Example 14, McCook 2011 teaches a gel comprising sodium copper chlorin e4 in an amount of 0.1% (pg. 18).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (G) may be employed, in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified McDaniel’s method by combining McDaniel’s linoleic acid, McCook 2011’s sodium copper chlorin e4 and sodium copper chlorin e6 in a combined amount of 0.1% (pg. 21), and placing these into Montanari’s Example 1 lotion because McDaniel’s linoleic acid and McCook 2011’s sodium copper chlorin e4 and sodium copper chlorin e6 are used to treating alopecia/baldness and Montanari’s Example 1 lotion is for stimulating hair growth. It is obvious to use them together to treat alopecia/baldness on the scalp. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to treat alopecia/baldness having an etiology from inflammation using a pharmacological lotion suitable for stimulating hair growth as taught by Montanari.
With regard to the recited amount of water, carrier/glycols/alcohol denatured, phospholipid, antioxidant, pH adjusting agent, and chelated copper chlorin compounds, the combined teachings of McDaniel, Montanari, and McCook 2011 teach these parameters with amounts which fall within or overlap with the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
As it pertains to claims 10 & 11 the ratio of terminal hair to vellus hairs increasing, these are statements of intended results from practicing the recited method. As described supra, McDaniel, Montanari and McCook 2011 teaches the recited method steps with the recited formulation. As such, the recited results would necessarily flow from practicing the method suggested by the combined teachings of McDaniel, Montanari and McCook 2011. Please note the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant's recited intended results differ from those achieved when McCook’s method is practiced. Therefore the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over McDaniel, Montanari, and McCook 2011, as applied to claims 1, 9-11, 32 & 33 above, and further in view of Klemp (Published: 1989; previously cited) and Liu (CN 110090211; Published: 08/06/2019; previously cited).
The teachings of McDaniel, Montanari, and McCook 2011 are described above in the rejection of claim 1. With respect to claim 2, the combined teachings suggest a lotion with sodium copper chlorin e6 making up 100% of (a) and sodium copper chlorin e4 (b)(i). McDaniel, Montanari and McCook 2011 express interest with hair loss/alopecia and inflammation.
Neither McDaniel, Montanari, and McCook 2011 teach inclusion of inclusion of copper chlorin p6.
In the same field of invention of alopecia, with regard to claim 2, Klemp teaches “one of the first clinical signs of a reduced peripheral blood flow is the loss of hair. It has been hypothesized that a reduced blood flow in the scalp might contribute to or cause hair loss.” (pg. 725).
With regard to claim 2 (b)(iii), Liu teaches phyllins for improvement in microcirculation disorders (title). The phyllins can include Green porphyrin of chlorin P6 and the transition metal chelate of the chlorophyllins may include copper (pg. 8 & 19).
Here at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled at the time of filing to have modified the method suggested by the combined teachings of McDaniel, Montanari, and McCook 2011, by adding copper chlorin p6 to the composition used in the method because the composition and method are used in the treatment of age-related alopecia and reduced blood flow/circulation is a factor contributing to alopecia as taught by Klemp with copper chlorin p6 improving microcirculation as taught by Liu. The ordinary skilled artisan would have been motivated to do so in order to treat one of the causes of alopecia.
With regard to the one or more chelated copper chlorin compounds comprising at least 30% by weight of a salt form of a copper isochlorin e4 as set forth by claims 27 & 46, it is obvious to select 50% copper (II) isochlorin e4 disodium salt and 50% copper chlorin P6 as a point to start optimization to treat alopecia through a reduction in inflammation and increase blood flow.
Claims 3, 4, 7, 20 & 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel, Montanari, McCook 2011, Klemp and Liu as applied to claims 1, 2, 9-11, 32 & 33 above, and further in view of Woodward (US 20150320661; previously cited), McCook [(Published: 08/12/2015); hereinafter McCook 2015(b); previously cited and referenced as McCook 2015(b)], Kamis (US 2002/0139384; Published: 10/03/2002; previously cited), and Mo (CA 3085973; Published 07/11/2019).
With regard to claim 3, McDaniel teaches application of the topical preparation to the scalp (i.e. an area that is 700 cm2) to slow or stop the microinflammation in scalp follicles that would otherwise lead to fibrosis and miniaturization of the follicle seen clinically as baldness [0018]. With regard to claims 3 & 4, McDaniel teaches in Example 1 that “this inventor has observed increased terminal (full sized) hair growth in the balding scalp of a 60 year-old man treated for five months for cystic acne with the medication” (i.e. 150 days; “(2) an average diameter of the terminal hairs increases by greater than 5% after the period of time compared to the average diameter prior to the period of time). With regard to claims 3, 4 & 20, McDaniel teaches following a competing product of minoxidil in which it took 6 months to observe hair growth when topically applied [0006]. It would have been prima facie obvious to the ordinary skilled artisan, at the time of filing, to have modified McDaniel’s method by adjusting the period of administration to 180 days (i.e. 6 months) because this is done in the alopecia arts because related topical products such as minoxidil take six months to regrow hair. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to select an administration period art recognized as suitable for observing hair regrowth. The combined teachings of McDaniel, Montanari, McCook 2011, Klemp and Liu suggest inclusion of the copper chlorins, sodium copper chlorin e4, sodium copper chlorin e6, and copper chlorin p6. With regard to claims 3 & 7, the ordinary skilled artisan would reasonably envisage 33.3% sodium copper chlorin e4, 33.3% sodium copper chlorin e6, and 33.3% and copper chlorin p6 as a place to start optimizing. With regard to claims 3, 38 & 39, Montanari teaches pentylene glycol and butylene glycol to be acceptable glycols for cosmetic applications [0061]. With regard to claims 3, 38, & 39, it would have been prima facie obvious before the effective filing date to have substituted the pentylene glycol with butylene glycol because both are acceptable glycols for cosmetic applications as suggested by Montanari.
Neither McDaniel, Montanari, McCook 2011, Klemp and Liu teach the dose of 0.2 mg to 1.0 mg of the chelated copper chlorin compound, inclusion of disodium copper (ii) isochlorin e4, the alcohol denatured is SD alcohol, 190 proof, or inclusion of 2-10% ethoxydiglycol.
In the same field of invention of treating hair loss in men or women (i.e. humans), with regard to claim 3, Woodward teaches a method of stimulating hair growth by applying a topical composition comprising 1 ng to 10 mg bimatoprost to the scalp per day (Woodward’s claims 21, 29, 30, 32 & 33; [0023]). With regard to claim 3, Woodward teaches “topical use on the skin and the scalp, the compound can be advantageously formulated using ointments, creams, liniments or patches as a carrier… Typically, the dose to be applied on the scalp is in the range of about 0.1 ng to about 100 mg per day… depending on the compound and the formulation” [0050].
McCook 2015(b) teaches inhibitors of hyaluronidase may serve as anti-inflammatory agents (abstract). McCook 2015(b) teaches sodium copper chlorophyllin complex showed a concentration dependent inhibition of hyaluronidase with a dose of 100 ug/ml inhibiting 100% of hyaluronidase activity (Table 2-pg. 446). With regard to claims 3 & 7, Table 3 showed the effects of the small molecule analogs in the sodium copper chlorophyllin complex on hyaluronidase activity with copper (II) isochlorin e4 disodium salt having the greatest inhibition with 100 ug/ml inhibiting 100% of hyaluronidase activity (Table 3-pg. 447). Copper (II) chlorin e6 trisodium salt and chorin e6 trisodium salt only had 24% and 21%, respectively inhibition of hyaluronidase (Table 3-pg. 447)/
With regard to claims 3, 36 & 39, in the related field of hair cosmetics, Kamis teaches in their Examples 1-3 styling compositions which use SD Alcohol 40 (190 proof; [0077]-[0079]).
With regard to claims 3, 37 & 39, Mo teaches a liquid dosage form for application to the skin containing at least one enhancer that promotes permeation of the pharmaceutically active agent through the skin (title; abstract). The enhancer may be diethylene glycol monoethyl ether in an amount of 1-10% (i.e. ethoxydiglycol; pg. 5, ll. 15-end to pg. 6, ll. 1-5; pg. 11; pg. 12. ll. 1-5). With regard to claim 3, propylene glycol and butylene glycol are taught as emulsifiers suitable for the invention (pg. 8, ll. 5-15). The active agent may be a hair growth promoting agent like minoxidil (pg. 12. ll. 1-5).
Here, at least rationale (F), may be employed where it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method suggested by the combined teachings of McDaniel, Montanari, McCook 2011, Klemp and Liu by applying 1 ng to 10 mg of the formulation to the scalp/700 cm2 area as suggested by Woodward because McDaniel, Montanari, and McCook are directed to treating hair loss and thinning hair by application of topical formulas to the scalp and known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to use the formulation suggested by the combined teachings of McDaniel, Montanari, McCook 2011, Klemp and Liu in amount that is art recognized suitable for application to the scalp/700 cm2 area to treat hair loss and age related-alopecia.
Here, at least rationale (B), may be employed where it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method suggested by the combined teachings of McDaniel, Montanari, McCook 2011, Klemp and Liu by substituting the sodium copper chlorin e6 with copper (II) isochlorin e4 disodium salt as suggested by McCook 2015 (b) because McDaniel suggests there is an inflammatory component to alopecia, McCook 2015(b) teaches inhibitors of hyaluronidase may serve as anti-inflammatory agents, and copper (II) isochlorin e4 disodium salt inhibits hyaluronidase completely at concentrations as low as 100 ug/ml.
Here at least rationale (B) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have replaced the generically taught alcohol denatured with SD alcohol 40 (190 proof) as suggested by Kamis because the composition suggested by the combined teachings of McDaniel, Montanari, McCook 2011, Klemp and Liu is a topical cosmetic lotion and Kamis teaches compositions which are applied to hair (i.e. topical) use 190 proof SD Alcohol 40. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to provide the denatured alcohol in a concentration art recognized suitable for topical administration.
Here, at least rationale (A) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the method suggested by the combined teachings of McDaniel, Montanari, McCook 2011, Klemp and Liu by adding 1-10% diethylene glycol monoethyl ether (i.e. ethoxydiglycol) as suggested by Mo because McDaniel, Montanari, McCook 2011, Klemp and Liu and Mo are directed to treating alopecia/stimulating hair growth by delivery of active agents through topical application of agents to the skin/scalp and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to enhance the penetration of the active agents linoleic acid and sodium copper chlorin e4 into the scalp/head skin.
With regard to the amount of the composition applied to the scalp/700 cm2 area, the combined teachings of McDaniel, Montanari, McCook 2011, Klemp, Liu, Woodward, McCook 2015(b), Kamis and Mo teach this parameter with values which overlap with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With regard to the recited amounts of disodium copper (II) isochlorin e4, copper chlorin p6, SD alcohol, 190 proof, butylene glycol, and ethoxydiglycol, the combined teachings of McDaniel, Montanari, McCook 2011, Klemp, Liu, Woodward, McCook 2015(b), Kamis and Mo teach these parameters with values which overlap with the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
With regard to claims 4 & 20, the density or diameter of the terminal hairs is necessarily increased as compared to an untreated person because the “miniaturization of the follicle seen clinically as baldness” is decreased as taught by McDaniel [0018]. Further, the combined teachings of McDaniel, Montanari, McCook 2011, Klemp, Liu, Woodward, McCook 2015(b), Kamis and Mo suggest a composition having the recited reagents in the recited amounts used in a method with the recited method steps. "Products of identical chemical composition can not have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McDaniel, Montanari, and McCook 2011, as applied to claims 1, 9-11, 32 & 33 above, and further in view of Cleveland Clinic (Published: 06/30/2020; previously cited).
With regard to claim 8, and the elected species, the teachings of McDaniel, Montanari, and McCook 2011 suggest a method of treating age-related alopecia and thinning hair.
Neither McDaniel, Montanari, nor McCook 2011 teach the method comprises administering an oral supplement comprising vitamins and minerals. McDaniel teaches an inflammatory component to age-related alopecia.
In the same field of invention, Cleveland Clinic “everyone has some hair loss with aging…All sexes experience hair loss for a variety of reasons as they age, such as…nutritional deficiencies” (pg. 3). Cleveland Clinic teaches adding a multivitamin once a day to replenish nutrients not fulfilled by the foods you eat (pg. 8)
Here, at least rationale (A) may be employed, in which it would have been prima facie to have modified the method suggested by the combined teachings of McDaniel, Montanari, and McCook 2011 by adding the step of oral supplementation with a once a day multivitamin as suggested to Cleveland Clinic because McDaniel and Cleveland Clinic are both directed to methods and compositions to treat age related alopecia. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to replenish nutrients with nutritional deficiencies recognized as one of the causes for age-related thinning hair as taught by Cleveland Clinic.
Claims 21 & 34 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel, Montanari, and McCook 2011, as applied to claims 1, 9-11, 32 & 33 above, and further in view of Gaunitz (US 2007/0184003; previously cited).
With regard to claim 21, McDaniel teaches finasteride (i.e. a 5-α reductase inhibitor which is a 4-azasteroid compound) has been developed and proven to cause regrowth of hair by blocking the only form of the 5-alpha reductase enzyme found only in prostate and scalp tissues [0006]. McDaniel teaches the finasteride is administered by the oral route [0006]. With regard to claim 34, Montanari in Example 1 teaches a lotion to stimulate hair growth comprising caprylyl glycol and “alcohol denat” [00097].
McDaniel does not teach topical application of the finasteride.
In the same field of invention of promoting hair growth, Gaunitz teaches topical application of finasteride (abstract).
Here, it would have been prima facie obvious to have modified the hair growth compositions suggested by the combined teachings of McDaniel, Montanari and McCook by adding finasteride (a 5-α reductase inhibitor which is a 4-azasteroid compound) as suggested by Gaunitz because McDaniel, Montanari, McCook and Gaunitz are all directed to methods and compositions for growing hair and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to promote hair growth by blocking the scalp 5-alpha reductase enzyme.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over McDaniel, Cronk (US 20080206156; Published: 08/28/2008), and McCook 2011.
McDaniel teaches a composition and a method for treating age-related alopecia (title). With regard to claim 26, in Example 3 McDaniel teaches “age-related hair thinning is a universal finding in human scalps beginning in the third decade of life” and teaches a potential mechanism for this P. acnes-induced microinflammation [0016]. With regard to claim 26, McDaniel teaches application of the topical preparation to the scalp (i.e. an area that is 700 cm2) to slow or stop the microinflammation in scalp follicles that would otherwise lead to fibrosis and miniaturization of the follicle seen clinically as baldness [0018]. With regard to claim 26, McDaniel teaches carriers including shampoos, sprays, and creams.
McDaniel does not teach inclusion of one or more chelated copper chlorin compounds in an amount comprising 0.02% to 0.1% by weight or the percentage of carrier comprising an alcohol and a glycol.
In the same field of invention of spray medications involving the scalp that are supplied an amount sufficient to stimulate or maintain hair growth, Cronk teaches “this spray medication is transparent on the scalp and does not need to be rubbed into the skin of the scalp to be effective in stimulating or maintaining hair growth” and that the carrier solution is a pharmacological carrier solution [0030]. In the Examples, Cronk teaches Carrier 2 which comprises 16.8% SD alcohol, ethanol or isopropanol and 20% propylene glycol which yields an alcohol and a glycol in a combined amount of 36.8% in a carrier which is close to the recited amount of 37%. A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). In the instant case, a carrier comprising an alcohol and a glycol in a combined amount of 36.8% and a carrier comprising an alcohol and a glycol in a combined amount of 37% are expected to have the qualities of delivering medication to the scalp in a transparent manner which the carrier being recognized as pharmacologically acceptable for spraying onto the scalp to deliver medication that stimulates or maintains hair growth as taught by Cronk (Cronk’s paragraph [0030]).
In the same field of invention of hair thinning, McCook 2011 teaches “A fifth aspect of the present invention is directed to methods and formulations for the topical treatment of thinning hair or alopecia comprising topical administration of (i) chlorophyllin, chlorin e4, chlorin e6, or ethyl esters of chlorin e4 or e6, the chlorins or chlorin ethyl esters preferably in the form of the sodium or potassium salts of their copper and zinc complexes” (i.e. sodium copper chlorin e6; [0014]). McCook 2011 also teaches a “further embodiment… directed to method of treatment of inflammatory dermatoses selected from the group consisting of… alopecia areata… The method includes the step of topically administering to an area of skin affected by the inflammatory dermatosis a composition comprising (i) chlorophyllin, chlorin e4, chlorin e6, or ethyl esters of chlorin e4 or e6, the chlorins or chlorin ethyl esters preferably in the form of the sodium or potassium salts of their copper and zinc complexes” (emphasis added; [0068]). In Example 14, McCook 2011 teaches a gel comprising water sodium copper chlorin e4 in an amount of 0.1% (pg. 21).
Here, at least rationale (G) may be employed, in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified McDaniel’s method by combining McDaniel’s linoleic acid, McCook 2011’s sodium copper chlorin e4 in an amount of 0.1% (pg. 21), and placing these into Cronk’s Carrier 2 pharmacological carrier because McDaniel’s linoleic acid and McCook 2011’s sodium copper chlorin e4 are used to treating alopecia/baldness and Cronk’s spray carrier is for the delivery of scalp medication without rubbing. It is obvious to use them together to treat alopecia/baldness on the scalp. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to treat alopecia/baldness having an etiology from inflammation using a pharmacological carrier suitable for delivery of scalp medication transparently to the scalp.
With regard to the recited amount of one or more chelated copper chlorin compounds, McCook 2011 teaches this parameter with amounts which fall within or overlap with the claimed range.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claims 27 & 46 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel, Cronk, and McCook 2011 as applied to claim 26 above, and further in view of in view of McCook [(Published: 08/12/2015); hereinafter McCook 2015(b); previously cited and referenced as McCook 2015(b)] and Klemp (Published: 1989; previously cited) and Liu (CN 110090211; Published: 08/06/2019; previously cited).
The teachings of McDaniel, Cronk, and McCook 2011 are described above. McCook 2011 teaches inclusion of sodium copper chlorin e4 (pg. 21). McDaniel and McCook 2011 express interest with hair loss/alopecia and inflammation.
Neither McDaniel, Cronk, nor McCook 2011 teach the sodium copper chlorin e4 is disodium copper chlorin e4 or inclusion of copper chlorin p6.
McCook 2015(b) teaches inhibitors of hyaluronidase may serve as anti-inflammatory agents (abstract). McCook 2015(b) teaches sodium copper chlorophyllin complex showed a concentration dependent inhibition of hyaluronidase with a dose of 100 ug/ml inhibiting 100% of hyaluronidase activity (Table 2-pg. 446). With regard to claims 27 & 46, Table 3 showed the effects of the small molecule analogs in the sodium copper chlorophyllin complex on hyaluronidase activity with copper (II) isochlorin e4 disodium salt having the greatest inhibition with 100 ug/ml inhibiting 100% of hyaluronidase activity (Table 3-pg. 447). With regard to claims 27 & 46, McCook 2015(b) teaches that as commercial sodium copper chlorophyllin ages the disodium copper isochlorin e4 oxidizes to oxidized copper isochlorin e4 (Table 4-pg. 447; pg. 447). With regard to claims 27 & 46, McCook 2015(b) teaches disodium oxidized copper isochlorin e4 had hyaluronidase inhibitory activity but it was lower than that of disodium copper isochlorin e4 (pg. 447). With regard to claims 27 & 46, McCook 2015(b) teaches that the new lot of Spectrum comprised 50% Copper isochlorin e4, disodium salt and 12% Oxidized copper isochlorin e4, disodium salt. With regard to claims 27 & 46, the ordinary skilled artisan at the time of filing recognized that in the new lot of Spectrum 80% of the Copper isochlorin e4, disodium salt is not oxidized and 20% of the Copper isochlorin e4, disodium salt is in oxidized form (pg. 447).
In the same field of invention of alopecia, with regard to claims 27 & 46, Klemp teaches “one of the first clinical signs of a reduced peripheral blood flow is the loss of hair. It has been hypothesized that a reduced blood flow in the scalp might contribute to or cause hair loss.” (pg. 725).
With regard to claims 27 & 46, Liu teaches phyllins for improvement in microcirculation disorders (title). The phyllins can include Green porphyrin of chlorin P6 and the transition metal chelate of the chlorophyllins may include copper (pg. 8 & 19).
Here, at least rationale (B) may be employed, in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method suggested by the combined teachings of McDaniel, Cronk, and McCook 2011 by substituting the sodium copper chlorin e4 with disodium copper chlorin e4 as suggested by McCook 2015(b) because alopecia has an inflammatory component as taught by McDaniel and copper (II) isochlorin e4 disodium salt has the greatest inhibition of hyaluronidase activity with inhibitors of hyaluronidase potentially serving as anti-inflammatory agents as taught by McCook 2015(b).
Here at least rationale (G) may be employed in which it would have been prima facie obvious to the ordinary skilled at the time of filing to have modified the method suggested by the combined teachings of McDaniel, Cronk, and McCook 2011, by adding copper chlorin p6 to the composition used in the method because the composition and method are used in the treatment of age-related alopecia and reduced blood flow/circulation is a factor contributing to alopecia as taught by Klemp with copper chlorin p6 improving microcirculation as taught by Liu. The ordinary skilled artisan would have been motivated to do so in order to treat one of the causes of alopecia.
With regard to the one or more chelated copper chlorin compounds comprising at least 30% by weight of a salt form of a copper isochlorin e4 as set forth by claims 27 & 46, it is obvious to select 50% copper (II) isochlorin e4 disodium salt and 50% copper chlorin P6 as a point to start optimization to treat alopecia through a reduction in inflammation and increase blood flow.
Claim 28-31 & 43 are rejected under 35 U.S.C. 103 as being unpatentable over McDaniel, Cronk, McCook 2011, McCook 2015(b), Klemp and Liu as applied to claims 26, 27 & 46, above, and further in view of in view of Woodward (US 20150320661; previously cited).
With regard to claims 28-30 & 43, McDaniel teaches in Example 1 that “this inventor has observed increased terminal (full sized) hair growth in the balding scalp of a 60 year-old man treated for five months for cystic acne with the medication” (i.e. 150 days; “(2) an average diameter of the terminal hairs increases by greater than 5% after the period of time compared to the average diameter prior to the period of time). With regard to claims 30 & 43, McDaniel teaches following a competing product of minoxidil in which it took 6 months to observe hair growth when topically applied [0006]. It would have been prima facie obvious to the ordinary skilled artisan, at the time of filing, to have modified McDaniel’s method by adjusting the period of administration to 180 days (i.e. 6 months) because this is done in the alopecia arts because related topical products such as minoxidil take six months to regrow hair. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to select an administration period art recognized as suitable for observing hair regrowth. With regard to claims 28 & 43, McDaniel teaches twice daily topical applications of an anti-alopecia medicament are messy and inconvenient [0006]. With regard to claims 28 & 43, the ordinary skilled artisan, at the time of filing, would have immediately envisaged a method of treating alopecia with once daily application of a topical, anti-alopecia medicant in order to reduce the messiness and inconvenience based upon McDaniel’s teachings. With regard to claim 31, the method suggested by the combined teachings of McDaniel, Cronk, McCook 2011, McCook 2015(b), Klemp and Liu do not require “the copper chlorin e6, the salt form of the copper chlorin e6, the oxidized form of the copper chlorin e6, or the oxidized form of the salt form of the copper chlorin e6”. To be clear, McCook 2015(b) teaches copper (II) isochlorin e4 disodium salt has the greatest inhibition of hyaluronidase activity and it oxidizes as it ages to oxidized copper isochlorin e4, disodium salt, with the isochlorin e4 disodium salt having the second highest inhibitory activity of the compounds examined (McCook 2015(b)’s Table 3 & 4). With regard to claim 30, McCook 2015(b) that as commercial sodium copper chlorophyllin ages the disodium copper isochlorin e4 oxidizes to oxidized copper isochlorin e4 (Table 4-pg. 447; pg. 447). With regard to claim 43, Liu teaches copper chlorin P6 increases blood flow.
Neither McDaniel, Cronk, McCook 2011, McCook 2015(b), Klemp nor Liu teach the dose per scalp (i.e. 700 cm2 area of hair growth) is 0.2 mg to 1.0 mg.
In the same field of invention of treating hair loss in men or women (i.e. humans), with regard to claim 28, Woodward teaches a method of stimulating hair growth by applying a topical composition comprising 1 ng to 10 mg bimatoprost to the scalp per day (Woodward’s claims 21, 29, 30, 32 & 33; [0023]). With regard to claim 28, Woodward teaches “topical use on the skin and the scalp, the compound can be advantageously formulated using ointments, creams, liniments or patches as a carrier… Typically, the dose to be applied on the scalp is in the range of about 0.1 ng to about 100 mg per day… depending on the compound and the formulation” [0050]. With regard to claim 28, Woodward teaches the compound may be administered once a day [0050].
With regard to claims 28 & 43, at least rationale (F), may be employed where it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method suggested by the combined teachings of McDaniel, Cronk, McCook 2011, McCook 2015(b), Klemp and Liu by applying 1 ng to 10 mg of the formulation to the scalp/700 cm2 area as suggested by Woodward because McDaniel, Cronk, McCook 2015(b), Klemp and Woodward are directed to treating hair loss and thinning hair by application of topical formulas to the scalp and known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to use the formulation suggested by the combined teachings of McDaniel, Cronk, McCook 2011, McCook 2015(b), Klemp and Liu in amount that is art recognized suitable for application to the scalp/700 cm2 area to treat hair loss and age related-alopecia.
With regard to the amount of the composition applied to the scalp/700 cm2 area, the combined teachings of McDaniel, Cronk, McCook 2011, McCook 2015(b), Klemp, Liu and Woodward teach this parameter with values which overlap with the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over McDaniel, Montanari, and McCook 2011, as applied to claims 1, 9-11, 32 & 33 above, and further in view of Mo and McCook 2015 (b).
The teachings of McDaniel, Montanari, and McCook 2011 are relied upon as above. In brief, McDaniel is relied upon to teach the method steps, linoleic acid, and the inflammatory component to alopecia. Montanari is relied upon to teach the hair stimulating lotion comprising water in overlapping amounts, denatured alcohol in overlapping amounts, butylene glycol in overlapping amounts, phosphatidylcholine in overlapping amounts, the antioxidant in overlapping amounts, the sodium hydroxide/pH adjusting agent in overlapping amounts. McCook 2011 teaches the amount of copper chorin in topical compositions which are used to treat alopecia areata (which has an inflammatory component).
Neither McDaniel, Montanari, and nor McCook 2011 teach inclusion of ethoxydiglycol or at least disodium copper (II) isochlorin e4.
The teachings of Mo are described above.
The teachings of McCook 2015 (b) are described above.
Here, at least rationale (A) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the method suggested by the combined teachings of McDaniel, Montanari, and McCook 2011 by adding 1-10% diethylene glycol monoethyl ether (i.e. ethoxydiglycol) because McDaniel, Montanari, and McCook 2011 are directed to treating alopecia/stimulating hair growth by delivery of active agents through topical application of agents to the skin and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to enhance the penetration of the active agents into the scalp/head skin.
Here, at least rationale (B) may be employed, in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the method suggested by the combined teachings of McDaniel, Montanari, and McCook 2011 by substituting the sodium copper chlorin e4 with disodium copper chlorin e4 as suggested by McCook 2015(b) [yielding a component (a) comprising 50% disodium copper chlorin e4] because alopecia has an inflammatory component as taught by McDaniel and copper (II) isochlorin e4 disodium salt has the greatest inhibition of hyaluronidase activity with inhibitors of hyaluronidase potentially serving as anti-inflammatory agents as taught by McCook 2015(b).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over McDaniel, Cronk, and McCook 2011 as applied to claim 26 above, and further in view of in view Mo (CA 3085973; Published 07/11/2019).
The teachings of McDaniel, Cronk, and McCook 2011 are described above. Cronk teaches the pharmacologically acceptable solution permits better absorption [0008]. Cronk teaches inclusion of water, 60% SD alcohol and propylene glycol in an amount of 20% in carrier 2 (Examples –[0043])
Neither McDaniel, Cronk, nor McCook 2011 teach inclusion of butylene glycol or ethoxydiglycol.
Mo teaches a liquid dosage form for application to the skin containing at least one enhancer that promotes permeation of the pharmaceutically active agent through the skin (title; abstract). The enhancer may be diethylene glycol monoethyl ether in an amount of 1-10% (i.e. ethoxydiglycol; pg. 5, ll. 15-end; pg. 6, ll. 1-5; pg. 11; pg. 12. ll. 1-5). Propylene glycol and butylene glycol are taught as emulsifiers suitable for the invention (pg. 8, ll. 5-15). The active agent may be a hair growth promoting agent like minoxidil (pg. 12. ll. 1-5).
Here, at least rationale (B) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the method suggested by the combined teachings of McDaniel, Cronk, and McCook 2011 by substituting the propylene glycol with butylene glycol because both are emulsifiers suitable for compositions which deliver active agents, including hair growth actives, through the skin as taught by Mo.
Here, at least rationale (A) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the method suggested by the combined teachings of McDaniel, Cronk, and McCook 2011 by adding 1-10% diethylene glycol monoethyl ether (i.e. ethoxydiglycol) because McDaniel, Cronk, and McCook 2011 are directed to treating alopecia/stimulating hair growth by delivery of active agents through topical application of agents to the skin and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to enhance the penetration of the active agents linoleic acid and sodium copper chlorin e4 into the scalp/head skin.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over McDaniel, Montanari, and McCook 2011, as applied to claims 1, 9-11, 32 & 33 above, and further in view of Mo and Kamis.
The teachings of McDaniel, Montanari, and McCook 2011 are relied upon as above. In brief, McDaniel is relied upon to teach the method steps, linoleic acid, and the inflammatory component to alopecia. Montanari is relied upon to teach the hair stimulating lotion comprising water in overlapping amounts, denatured alcohol in overlapping amounts, butylene glycol in overlapping amounts, phosphatidylcholine in overlapping amounts.
Neither McDaniel, Montanari, and nor McCook 2011 teach inclusion of ethoxydiglycol or at least disodium copper (II) isochlorin e4 or that the denatured alcohol is SD alcohol, 190 proof.
The teachings of Mo are described above.
The teachings of Kamis are described above.
Here, at least rationale (A) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified the method suggested by the combined teachings of McDaniel, Montanari, and McCook 2011 by adding 1-10% diethylene glycol monoethyl ether (i.e. ethoxydiglycol) as suggested by Mo because McDaniel, Montanari, and McCook 2011 are directed to treating alopecia/stimulating hair growth by delivery of active agents through topical application of agents to the skin and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to enhance the penetration of the active agents into the scalp/head.
Here at least rationale (B) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have replaced the generically taught alcohol denatured with SD alcohol 40 (190 proof) as suggested by Kamis because the composition suggested by the combined teachings of McDaniel, Montanari, and McCook 2011 is a topical cosmetic lotion and Kamis teaches compositions which are applied to hair (i.e. topical) use 190 proof SD Alcohol 40. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to provide the denatured alcohol in a concentration art recognized suitable for topical administration.
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over McDaniel (US 2009/0197954; 08/06/2009; previously cited) and McCook [WO 2011/050102; hereinafter McCook 2011, previously cited and referenced as McCook 2011].
Claim Analysis: It is noted that transitional phrase “consists essentially of” is not defined by the as filed specification. The transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps “and those that do not materially affect the basic and novel
characteristic(s)” of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (emphasis in original). “Absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355.(MPEP 2111.03.III). In the instant case, the as filed specification teaches inclusion of anti-inflammatory agent (pg. 8).
McDaniel teaches a composition and a method for treating age-related alopecia with linoleic acid which is an art recognized fatty acid compound and emollient (title). With regard to claim 47, in Example 3 McDaniel teaches “age-related hair thinning is a universal finding in human scalps beginning in the third decade of life” and teaches a potential mechanism for this P. acnes-induced microinflammation [0016]. As such, McDaniel teaches a link between age-related alopecia and inflammation. With regard to claim 47, McDaniel teaches application of the topical preparation to the scalp (i.e. an area that is 700 cm2) to slow or stop the microinflammation in scalp follicles that would otherwise lead to fibrosis and miniaturization of the follicle seen clinically as baldness [0018]. With regard to claim 47, McDaniel teaches the composition comprises a carrier vehicle (McDaniel’s claim 17). With regard to claim 47, McDaniel teaches application of the topical preparation to the scalp (i.e. an area that is 700 cm2) to slow or stop the microinflammation in scalp follicles that would otherwise lead to fibrosis and miniaturization of the follicle seen clinically as baldness [0018]. With regard to claim 47, the density or diameter of the terminal hairs is necessarily increased as compared to an untreated person because the “miniaturization of the follicle seen clinically as baldness” is decreased [0018]. With regard to claim 47, McDaniel teaches in Example 1 that “this inventor has observed increased terminal (full sized) hair growth in the balding scalp of a 60 year-old man treated for five months for cystic acne with the medication” which is 13-cis-retinoic acid/a retinoid (i.e. 150 days; “(2) an average diameter of the terminal hairs increases by greater than 5% after the period of time compared to the average diameter prior to the period of time).
McDaniel does not teach inclusion of one or more chelated copper chlorin compounds in an amount of 0.02% to 0.1% or that the topical hair volumizing composition consists essentially of “water…and 0.02-0.1% of a chelated copper chorin compound”.
In the same field of invention of hair thinning, McCook 2011 teaches “A fifth aspect of the present invention is directed to methods and formulations for the topical treatment of thinning hair or alopecia comprising topical administration of (i) chlorophyllin, chlorin e4, chlorin e6, or ethyl esters of chlorin e4 or e6, the chlorins or chlorin ethyl esters preferably in the form of the sodium or potassium salts of their copper and zinc complexes” (i.e. sodium copper chlorin e6; [0014]). McCook 2011 also teaches a “further embodiment… directed to method of treatment of inflammatory dermatoses selected from the group consisting of… alopecia areata… The method includes the step of topically administering to an area of skin affected by the inflammatory dermatosis a composition comprising (i) chlorophyllin, chlorin e4, chlorin e6, or ethyl esters of chlorin e4 or e6, the chlorins or chlorin ethyl esters preferably in the form of the sodium or potassium salts of their copper and zinc complexes” (emphasis added; [0068]). McCook teaches the suitability of the ethylhexyl stearate which is an art recognized fatty compound and emollient (Example 1 –[0037]; Example 45-[0164]). In Example 15, McCook 2011 teaches a gel comprising water, butylene glycol and simethicone emulsion (i.e. carrier), lecithin (i.e. phospholipid), vitamin E acetate (i.e. antioxidant), sodium hydroxide (pH adjusting agent) and sodium copper chlorin e6 containing gel in an amount of 0.1% [0101]. In Example 14, McCook 2011 teaches a gel comprising sodium copper chlorin e4 in an amount of 0.1% (pg. 18).
Here, at least rationale (G) may be employed, in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified McDaniel’s method by combining McDaniel’s linoleic acid and McCook 2011’s Example 15 gel because McDaniel teaches microinflammation to be one of the mechanisms that contribute to age related alopecia and McCook 2011 teaches embodiments in which “chlorin e6 …. preferably in the form of the sodium or potassium salts of their copper and zinc complexes” including sodium copper chlorin e6 may serve as to treat regions of inflammatory dermatosis and regions of thinning hair.
With regard to recited amount of chelated copper chlorins present in the composition, the combined teachings of McDaniel and, McCook 2011 suggest this parameter with values which overlap or lie within the claimed ranges In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant argues that all pending claims are allowable over the cited references for the same reason that claims 40, 42, and 46 were not subject to rejection (reply, pg. 20).
This is not persuasive. Claim 46 was rejected under 35 USC 103 (a) over McDaniel, McCook 2011, Klemp and Liu (pg. 15; Action mailed 10/15/2025). Next, the claims are not of the same scope as claims 40 & 42 (see for example instant claim 1 which is missing the ethoxydiglycol). The scope of claim 40 has changed in that it no longer recites an amount of copper chlorin compounds. The percentages recited in claims 40 and 42 were previously in relation to the carrier and are now recited to be based on the composition resulting in a change of scope. 35 USC 112 rejections were made regarding these percentages and what structure they were based (just the carrier versus entire composition) and by addressing these issues by amendment to the claims by Applicant’s representative, the claim analysis changed because the structure in which the percentages were based changed and new art was identified and applied (see pg. 8; Action mailed 10/15/2025)
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 43 & 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 10, 12-15 & 18-21 of copending Application No. 19/192,917 (hereinafter the ‘917; Filed: 04/29/2025; Published: 08/14/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘917 are drawn to a method of treating human hair thinning resulting from aging comprising the step of administering a dose of a treatment composition comprising one or more active agents in an amount of 0.001 to 0.15 in which the active ingredients include copper chlorin e6 (i.e. one or more chelated copper chlorin compounds comprise at least 75% by weight of copper chlorin e6). The ‘917 explicitly recites that copper chlorin comprises at least 30% by weight of trisodium copper II chlorin e6 and also include disodium copper isochlorin e4, chlorin e4, copper pheophorbide a. The ‘917 recite the treatment period is at least 160 days wherein the period of consecutive days is at least 80 days. The ‘917 recites the treatment composition is in liquid form and the dose is around 0.001 to 0.002 grams (i.e. 1 to 2 mg) with the dose per 700 cm2 being around 0.3 to around 3 grams of the composition.
The copending claims are therefore an obvious variant of the conflicting copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s representative makes no arguments pertaining to the outstanding double patenting rejections. No terminal disclaimer has been filed. As such, the rejection are maintained.
Claims Free of the Prior Art
Claims 44 & 45 are non-obvious over the prior art.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David J Blanchard can be reached at 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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